Class 2 Device Recall Grafton DBM Putty

• Date Initiated by Firm: April 20, 2012
• Date Posted: October 18, 2012
• Recall Status: Terminated on January 17, 2014
• Recall Number: Z-0083-2013
• Recall Event ID: 62569
• 510(K)Number: K042707 K043048 K051188 K051195
• Product Classification: Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
• Product: Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
• Code Information: Multiple Lots - please see attachment
• Recalling Firm/ Manufacturer: Osteotech Inc; 51 James Way; Eatontown NJ 07724-2272
• For Additional Information Contact: Mr. Eric Epperson; 901-344-1435
• Manufacturer Reason for Recall: Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
• FDA Determined Cause: Device Design
• Action: Osteotech sent out recall letters/questionairres dated April 20, 2012, to Risk Managers/service representatives. The recall was expanded on August 1 2012. The letter identified the product, the problem, and the action to be taken by the customer. Sales Representatives would facillitate the return of any affected product they may have or provide cautionary labels for any affected product and/or support in the completion of the attached questionnaire. Customers were asked to disseminate this information to additional personnel within their facility as appropriate and return the questionnaire to Medtronic.. Customers with questions should contact their Medtronic Sales Representative at 800-876-3133, extension 3197. For questions regarding this recall call 732-542-2800. Osteotech sent an additional letter stating that The OPTIUMTM (DBM) product line was added in error.
• Quantity in Commerce: 37, 970 units
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MBP